Ex Parte Adams et al

Board of Patent Appeals and Interferences

Apr 19, 2010

10338081 (B.P.A.I. Apr. 19, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte CARDIAC DIMENSIONS, INC.
____________________

Appeal 2009-013045
Application 10/338,081
Technology Center 3700
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Decided: April 19, 2010
____________________

Before SALLY GARDNER LANE, JAMESON LEE, and
SALLY C. MEDLEY, Administrative Patent Judges.

LEE, Administrative Patent Judge.

DECISION ON APPEAL

A. STATEMENT OF THE CASE
This is a decision on appeal by the real party in interest, Cardiac
Dimensions, Inc. (“Cardiac Dimensions”), under 35 U.S.C. § 134(a) from a
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final rejection of claims 46-63. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

References Relied on by the Examiner
Blake et al. (“Blake”) 3,995,623 Dec. 7, 1976
Routh 6,096,064 Aug. 1, 2000
Mathis et al. (“Mathis”) 6,643,546 B2 Nov. 4, 2003

The Rejections on Appeal
The Examiner rejected claims 46-54 under 35 U.S.C. § 102(e) as
anticipated by Mathis.
The Examiner rejected claims 46, 47, and 49-63 under 35 U.S.C.
§ 102(b) as anticipated by Routh.
The Examiner rejected claims 46-48, 51, and 53-55 under 35 U.S.C.
§ 102(b) as anticipated by Blake.

The Invention
The invention relates to a method for the treatment of cardiac valve
dysfunction. (Spec. 1:5-6.)
Independent claim 46 is reproduced below (App. Br. 16 Claims
App’x.):
A method for treating cardiac valve dysfunction,
comprising:

(a) implanting a lead with electrodes in a patient such that the
electrodes are in electrical communication with muscle tissue
proximate to a cardiac valve to be treated; and

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(b) delivering electrical energy to the electrodes to stimulate
contraction of the muscle tissue, and thereby exert a constricting
pressure on the cardiac valve.
B. ISSUES
1. Has Cardiac Dimensions shown that the Examiner was
incorrect in finding that each of Mathis and Routh discloses the claim step of
delivering electrical energy to electrodes in a heart to stimulate contraction
of the muscle tissue, and thereby exert a constricting pressure on a cardiac
valve?
2. Has Cardiac Dimensions shown that the Examiner was
incorrect in finding that Mathis discloses the claim step of detecting an
electrical complex, specifically a P-wave, in a patient’s heart and delivering
electrical energy to electrodes in the heart based on the detection of the
electrical complex?
C. FINDINGS OF FACT
Cardiac Dimensions’ specification
1. Cardiac Dimensions’ specification discloses that an electrical
complex is an indicator of muscle contraction within the heart. (Spec. 3:13-
20.)
2. The specification further discloses that a “P-wave” is an
electrical complex that signals contraction of the atria. (Id. at 7:5-13).
Mathis
3. Mathis discloses a system for applying cardiac stimulation
using multiple electrodes. (Mathis 1:10-13.)
4. Mathis states (id. at 3:36-45):
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[A]n implantable cardiac stimulation system is disclosed with a
stimulator adapted to sense intrinsic cardiac activity and to
generate a stimulation pulse or pulses responsive to intrinsic
cardiac activity, said stimulation pulse or pulses having an
amplitude associated with a stimulation threshold; and a
plurality of implanted electrodes including at least one optimum
electrode selected based on a physiologic parameter related to
cardiac efficiency. Stimulation of the heart for a selected
chamber usually begins at the optimum electrode or electrodes.
Additional electrodes are implanted in a patient’s heart.

5. Mathis also describes that types of cardiac activity include
contractions of the heart, i.e., contraction of muscles in either an atrium or a
ventricle of the heart, and that those contractions are considered “intrinsic” if
first detected at an “optimum” electrode. (Id. at 13:41-64.)
6. An electrode is “optimum” when, for a given occurrence of a
cardiac muscle contraction, it is the electrode that is positioned closest to the
particular muscle undergoing contraction. (Id. at 12:9-34.)
7. Mathis further describes that contraction of the atrium of a heart
generates a “P-wave” that may be detected. (Id. at 1:41-42.)
8. Mathis also states (id. at 15:42-52):
Both sources of left ventricular inefficiency may be treated by
appropriate stimulation to contract or stiffen heart muscles.
Stimulation through at least one and preferably two or more
electrodes lying along the septal wall in the right ventricle may
so stiffen the septum that flutter or oscillation is reduced and
cardiac performance is improved. Similarly, stimulation
through at least one electrode in or near the right ventricle
outflow tract may propagate into the base of the left ventricle,
stiffening the muscular structures around the mitral valve and
increasing left ventricular output.

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9. Mathis discloses that its Figure 24 illustrates a way of
performing diagnostic and therapeutic functions that is alternative to other
ways that are disclosed in other portions of its disclosure. (Id. at 19:16-19.)
Routh
10. Routh discloses a cardiac stimulation device for pacing the
chambers of a heart. (Routh 1:6-10.)
11. “Pacing” of the heart involves delivery of electrical pulses to
electrodes implanted in a patient’s heart to stimulate the heart so that it will
beat at a desired rate. (Id. at 2:3-7.)
12. Routh states (id. at 2:37-44):
It is believed that pacing the left side of the heart, and in
particular the left ventricle can improve circulation. More
specifically, the left ventricle can be paced simultaneously with
atrial pacing or shortly after a sensed atrial event, so that the
ventricle contracts as blood flows into it from the left atrium.
This accelerated ventricular pacing reduces regurgitation
through the mitral valve, increases forward blood flow and
helps prevent the left ventricle from overfilling.

13. As is disclosed in Routh, the mitral valve separates the left
ventricular chamber from the left atrial chamber. (Id. at 1:38-42)
D. PRINCIPLES OF LAW
Anticipation is established when a single prior art reference discloses
all elements of the claimed invention. In re Spada, 911 F.2d 705, 708 (Fed.
Cir. 1990).

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E. ANALYSIS
The rejection based on Mathis
The Examiner rejected claims 46-54 as anticipated by Mathis. Claims
47 and 49-54 are argued collectively with independent claim 46. Claim 48
is separately argued.
Claims 46, 47, and 49-54
The dispute centers on the following limitation of claim 46:
“delivering electrical energy to the electrodes to stimulate contraction of the
muscle tissue, and thereby exert a constricting pressure on the cardiac
valve.” (App. Br. 16 Claims App’x.) The Examiner determined that that
limitation is disclosed in Mathis, citing column 15, lines 44-52. (Ans. 7:12-
14.) Cardiac Dimensions argues that the section of Mathis referenced by the
Examiner discloses only the act of stiffening heart muscle which is allegedly
not the same as constricting a cardiac valve. (App. Br. 7:27-8:2.)
Cardiac Dimensions’ argument is unpersuasive. The above-noted
portion of Mathis is reproduced below (Mathis 15:42-52):
Both sources of left ventricular inefficiency may be treated by
appropriate stimulation to contract or stiffen heart muscles.
Stimulation through at least one and preferably two or more electrodes
lying along the septal wall in the right ventricle may so stiffen the
septum that flutter or oscillation is reduced and cardiac performance is
improved. Similarly, stimulation through at least one electrode in or
near the right ventricle outflow tract may propagate into the base of
the left ventricle, stiffening the muscular structures around the
mitral valve and increasing left ventricular output.

[Emphasis added].

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Thus, Mathis discloses that electrical stimulation of the heart muscles
causes them to “contract or stiffen.” The terms “contract” and “stiffen” are
used as equivalents of one another in describing the reaction of muscles to
stimulation. In other words, as the muscles stiffen they also contract. The
term “contract” means “to reduce to a smaller size by or as if by squeezing
or forcing together.” Merriam Webster’s Collegiate Dictionary 250 (10th ed.
1996.) Mathis further describes that the stimulation causes the muscles to
stiffen, i.e., contract, “around the mitral valve” which increases ventricular
output. Cardiac Dimensions does not meaningfully explain why the
disclosure of contracting or squeezing together heart muscle around the
mitral valve is not reasonably viewed as a disclosure of exerting a
constricting pressure on a cardiac valve, as is required by the claims.
We sustain the rejection of claims 46, 47 and 49-54 as anticipated by
Mathis.
Claim 48
Claim 48 is dependent on claim 47 which is in turn dependent on
claim 46. Claims 47 and 48 are reproduced below (App. Br. 16 Claims
App’x.):
47. The method of Claim 46, further comprising detecting an
electrical complex in the patient's heart and delivering the electrical
energy to the lead electrodes based on the detection of an electrical
complex.

48. The method of Claim 47, in which the electrical complex is a P-
wave.

In arguing claim 48, Cardiac Dimensions urges that the claim requires
detection of an electrical complex, specifically a P-wave, in a patient’s heart,
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and in response delivers electrical energy to electrodes in the heart. An
electrical complex is an indicator of muscle contraction within the heart
(Spec. 3:13-20) and, in particular, a “P-wave” signals contraction of the
atria. (Id. at 7:5-13). The Examiner found that Mathis discloses that P-
waves are a known electrical complex that represents the occurrence of atrial
contraction. (Ans. 7:18-19.) The Examiner also found that Mathis discloses
the step of delivering electrical energy to electrodes placed within the heart
based on a detected electrical complex. (Id. at 7:15-17.)
According to Cardiac Dimensions, Mathis discloses applying
electrical energy only when a heart has failed to contract, i.e., only in the
absence of a detected electrical complex. Cardiac Dimensions argues that
that disclosure is the opposite of what is required in claim 48. In support of
that argument, Cardiac Dimensions points to Mathis’ Figure 24. (App. Br.
8:12-9:6.)
Cardiac Dimensions’ argument is misplaced. Mathis’ Figure 24
merely describes one embodiment of its invention. Mathis’ teachings are
not limited to only what is disclosed in Figure 24. Indeed, Mathis discloses
that that figure illustrates a way of performing diagnostic and therapeutic
functions that is alternative to other ways that are disclosed in other portions
of its disclosure. (Mathis 19:16-19.) Thus, even if what is disclosed in
Figure 24 is insufficient to meet the requirements of claim 48, that does not
end the anticipation inquiry based on Mathis.
In rejecting Cardiac Dimensions’ claim 48, the Examiner pointed in-
part to the following portion of Mathis (Mathis 3:36-45):
[A]n implantable cardiac stimulation system is disclosed with a
stimulator adapted to sense intrinsic cardiac activity and to generate a
stimulation pulse or pulses responsive to intrinsic cardiac activity, said
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stimulation pulse or pulses having an amplitude associated with a
stimulation threshold; and a plurality of implanted electrodes
including at least one optimum electrode selected based on a
physiologic parameter related to cardiac efficiency. Stimulation of the
heart for a selected chamber usually begins at the optimum electrode
or electrodes. Additional electrodes are implanted in a patient’s heart.

Thus, Mathis discloses that its system operates to generate stimulation
pulses to various electrodes that are implanted within the heart in response to
“intrinsic cardiac activity.” Mathis also describes that types of cardiac
activity include contractions of the heart, i.e., contraction of muscles in
either an atrium or a ventricle of the heart, and that those contractions are
considered “intrinsic” if first detected at an “optimum” electrode. (Id. at
13:41-64.) An electrode is “optimum” when, for a given occurrence of a
cardiac muscle contraction, it is the electrode that is positioned closest to the
particular muscle undergoing contraction. (Id. at 12:9-34.) Mathis further
describes that contraction of the atrium of a heart generates a “P-wave” that
may be detected. (Id. at 1:41-42.) Accordingly, Mathis’ disclosure
encompasses the generation of electric energy at electrodes within the heart
based on the detection of P-waves due to the contraction of atrial heart
muscle. In light of that disclosure, we conclude that Cardiac Dimensions
has not shown that the Examiner was incorrect in rejecting its claim 48 as
anticipated by Mathis.
We sustain the rejection of claims 48 as anticipated by Mathis.
The rejection based on Routh
The Examiner rejected claims 46, 47, and 49-63 as anticipated by
Routh. Cardiac Dimensions argues claims 47 and 49-63 collectively with
independent claim 46. In challenging the Examiner’s rejection, Cardiac
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Dimensions cites to Routh at column 2, lines 37-44. That portion of Routh
is reproduced below:
It is believed that pacing the left side of the heart, and in
particular the left ventricle can improve circulation. More
specifically, the left ventricle can be paced simultaneously with atrial
pacing or shortly after a sensed atrial event, so that the ventricle
contracts as blood flows into it from the left atrium. This accelerated
ventricular pacing reduces regurgitation through the mitral valve,
increases forward blood flow and helps prevent the left ventricle from
overfilling.

“Pacing” of the heart involves delivery of electrical pulses to
electrodes implanted in a patient’s heart to stimulate the heart so that it will
beat at a desired rate. (Routh 2:3-7.) Thus, the above-quoted section of
Routh discloses that electrical signals are delivered to electrodes implanted
in the left ventricle of a heart and contract the ventricle in order to reduce
regurgitation, i.e., back flow, of blood through the mitral valve. The mitral
valve separates the left ventricular chamber from the left atrial chamber. (Id.
at 1:38-42.)
In assessing the disclosure of Routh, Cardiac Dimensions states (App.
Br. 6:20-23):
Routh does not say that such pacing constricts the mitral valve,
however, nor is mitral valve constriction a necessary result of such
pacing. For example, the reduced mitral valve regurgitation suggested
by Routh could be from increased pressure in the left atrium
coinciding with or just preceding increased pressure in the left
ventricle.

Thus, Cardiac Dimensions’ position is that Routh’s disclosure of
contracting the ventricle does not reflect a contraction or constriction of the
mitral valve to provide reduced regurgitation. Rather, according to Cardiac
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Dimensions, some other reason accounts for the reduction and speculates
that one possible reason is increased pressure in the left atrium coinciding
with increased pressure in the right ventricle.
Cardiac Dimensions’ assertion is unpersuasive. The above-quoted
section of Routh does not use the term “increased pressure” or describe any
pressure variations. Neither does Cardiac Dimensions point to support in
any other part of Routh or any other evidence, such as declaration testimony,
substantiating its assertion that “increased pressure” is the mechanism
operating to reduce backflow through the mitral valve. The assertion is not
only speculation but also merely attorney argument, which cannot take the
place of evidence lacking in the record. Estee Lauder Inc. v. L'Oreal, S.A.,
129 F.3d 588, 595 (Fed. Cir. 1997).
Moreover, the plain and straight-forward reading of the above-quoted
portion of Routh is to connect the outcome of reduced regurgitation through
the mitral valve which is described in the last sentence of the portion with
the action of ventricle contraction described in the immediately preceding
sentence. In other words, those sentences taken together reasonably describe
that the act of contraction or squeezing together portions of the ventricle
exerts a constricting force on the mitral valve to reduce backflow of blood
through the valve. Indeed, that reading is consistent with other portions of
Routh describing that distortion of the ventricle causes distortion of the heart
valves. (Routh 2:21-22.) Cardiac Dimensions’ position, on the other hand,
is strained as it disassociates the content of the two sentences and relies on
speculation as to what mechanism actually causes the backflow reduction
through the mitral valve. On this record, we are not persuaded that the
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Examiner was incorrect in rejecting Cardiac Dimensions’ claim 46 over
Routh.
We sustain the rejection of claims 46, 47, and 49-63 as anticipated by
Routh.
The rejection based on Blake
The Examiner also alternatively rejected claims 46-48, 51, and 53-55
as anticipated by Blake. Because we have already sustained the rejection of
each of claims 46-48, 51, and 53-55 over prior art, we need not reach the
merits of the Examiner’s alternative rejection of those claims over Blake.
F. CONCLUSION
1. Cardiac Dimensions has not shown that the Examiner was
incorrect in finding that each of Mathis and Routh discloses the claim step of
delivering electrical energy to electrodes in a heart to stimulate contraction
of the muscle tissue, and thereby exert a constricting pressure on a cardiac
valve.
2. Cardiac Dimensions has not shown that the Examiner was
incorrect in finding that Mathis discloses the claim step of detecting an
electrical complex, specifically a P-wave, in a patient’s heart and delivering
electrical energy to electrodes in the heart based on the detection of the
electrical complex.
G. ORDER
The rejection of claims 46-54 under 35 U.S.C. § 102(e) as anticipated
by Mathis is affirmed.
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The rejection of claims 46, 47, and 49-63 under 35 U.S.C. § 102(b) as
anticipated by Routh is affirmed.
We do not reach the merits of the rejection of claims 46-48, 51, and
53-55 under 35 U.S.C. § 102(b) as anticipated by Blake.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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